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【JOPS】バリデーションマネジメントグループマネージャー, Technical Operation

Местоположение Maihara, Сига, Япония Идентификатор вакансии R-101803 Дата публикации 03/09/2021

【職務内容 / Job Description】


Validation Group Manager governs validation processes and execution to ensure operating processes in Quality Control testing, inspection, packing, distribution and storage are in compliance with laws, regulations, AZ Standards and current industry standards in GMP area

Below listed categories are also under responsibility of Validation group which is managed by Validation Group Manager.
Cleaning Validation / Computerized System Validation / Manufacturing, utility equipment and QC equipment qualification / Process validation / Continued process verification / Shipping validation / Validation Master Plan & Report / Calibration / Maintenance

【経験 / Experience】
<必須 Mandatory>

  • Experiences of validation/qualification more than 3 years

<歓迎 Nice to have>

  • QA, Calibration, Maintenance, Project management

【資格 / License】

<必須 Mandatory>

None

<歓迎 Nice to have>

None

【能力 / Skill-set】

<必須 Mandatory>

  • Technical skills and knowledge of inspection and packing process/utility/QC equipment
  • Professional level of knowledge of equipment qualification/computerized systems/cleaning/process validation
  • Professional knowledge of production process management
  • Sophisticated level of GMP/SHE knowledge
  • Coaching & communication

<歓迎 Nice to have>

  • Practical level of English
  • Project/program management
  • Sophisticated level of GMP management
  • Chemical or mechanical background

【語学 / Languages】

<必須 Mandatory>

  • 日本語 Japanese: Native level
  • 英語 English: None

<歓迎 Nice to have>

  • English : TOEIC score >730


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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